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How antibody USAN and INN sing a different tune

August 17, 2017 by The Antibody Society

We recently reported about the new World Health Organization (WHO) naming scheme for antibody therapeutics which resulted in deleting the source infix in international nonproprietary names (INN) (Parren, Carter & Plückthun, MAbs 2017 9:898-906). The changes implemented remove critical ambiguities in antibody naming going forward.

The WHO has now released the full executive summary of the 64th Consultation on International Nonproprietary Names for Pharmaceutical Substances at which the decision to remove the source infix was taken. The summary is in full agreement with the information previously provided in our perspective.  Notably, the new scheme will change the sounds of antibody names that have become so familiar to us (see Table 1). This diversification is in fact quite important as distinct names are thought to further reduce the potential for medication errors as more therapeutic antibodies make it to the market.

Alignment of INNs with United States Adopted Names (USAN) is essential since (approved) antibody therapeutics will usually carry both an INN and a USAN. We are therefore very pleased to report that the USAN Council has agreed to implement the same naming scheme. Eliminating the source infix also ends an important disagreement between the USAN Council and WHO on how the source infix should be defined and assigned (also see Parren et al. Mabs 2017 for more information). Importantly, it is noted that no changes to previously assigned USAN names are contemplated. Similarly, WHO notes that substituting previously assigned INNs requires extraordinary circumstances such as medication, prescription or distribution errors that occur due to name similarities, also indicating that existing INN will unlikely be changed.

Notably, the WHO stresses the importance of careful dissemination of information on the new scheme and highlights the role of The Antibody Society. Consequently we will continue to update you via this channel as new information becomes available.

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Filed Under: International non-proprietary names Tagged With: International nonproprietary names, United States Adopted Names, World Health Organization

Mouse vs Pan

July 25, 2017 by The Antibody Society

By William R (Bill) Strohl, BiStro Biotech Consulting LLC,  7-25-17

This is the first of several blogs that I will be writing for The Antibody Society on topics in the field of therapeutic antibodies and proteins that I find of interest.  The intention of these blogs is to stimulate thought and discussion about various aspects of therapeutic antibodies and related molecules, something that anyone reading on this website ought to appreciate.  For my first blog, I thought I would tackle an age-old (at least since the 1990s) discussion point concerning the use of transgenic mice producing human antibodies vs panning human libraries as preferred sources for fully human antibodies.  Virtually everyone with whom I have had the opportunity to discuss this topic has an opinion on it, some of which are rather strong.  That should make this all the more fun!  Moreover, 2017 appears, at least thus far, to be the year of the fully human antibody.  Thus far (to 7/23/17), 23 innovative drugs have been approved by the US Food and Drug Administration (FDA), seven of which are monoclonal antibodies.  Of those, six are fully human antibodies!

I’ll start out by reminiscing about antibody meetings in the timeframe of around 2000-2001, before any fully human antibodies were approved for marketing and commercial use.  In those days, scientists from the big four, i.e., Medarex and Abgenix on the transgenic mouse side, and Cambridge Antibody Technology (CaT) and Morphosys on the human antibody library side, would give talks at meetings, often back to back, on their platforms.  Of course, as would be expected, each group would expound on the positives for their particular approach, while finding negatives, or minimally providing neutral comments, for the others.  Coffee breaks and lunches at those meetings were typically filled with discussion about which approach, transgenic mouse or human antibody library panning, was better.  It was a fun time, watching, listening to, and participating in those discussions.  I’m sure that in many venues, vigorous discussions along the line of “Mouse vs Pan” still continue.

I will say up front that I don’t particularly have a favorite, because I see the potential use of both approaches.  Anecdotally, over my career I have been involved with many programs that were sourced from Balb/c mice and then humanized, transgenic mice producing human antibodies, and human antibody libraries, and I can’t say categorically that I’ve seen that a trend for “better antibodies” coming from one source or another.  It turns out that one of the worst behaved antibodies we made actually came from a Balb/c mouse, and it took intense phage-based engineering to improve the antibody into one that could potentially be developed.

First, though, to the statistics:  we all know that the first “fully human” antibody to be approved for commercial use, and the most valuable antibody on the market today, is adalimumab, marketed by Abbvie under the name of Humira®.  Approved by the US FDA in December, 2002, Humira® was used to treat nearly a million patients in 2016 and generated over US $16 billion in gross revenues.  Adalimumab was sourced from the CaT human antibody library using a technology called guided selection.

With the very recent approval of Janssen R&D’s guselkumab, there are now 75 antibodies and Fc fusion proteins approved by major regulatory agencies, according to my database.  Of these, 25 (one-third!) are fully human antibodies, 18 of which were derived from transgenic mice producing human antibodies and seven derived from human antibody libraries.  Additionally, there are currently 69 antibodies and Fc fusion proteins in Phase III clinical trials, 20 of which are fully human antibodies.  Of these 20 late clinical stage human antibody candidates, 10 are from transgenic mice, six were derived from human antibody libraries, and four are sourced directly from human B cells (i.e., the new kid on the block).  Combining the approved and Phase III numbers leaves us with 28 approved or late stage human antibodies sourced from transgenic mice, 13 sourced from human antibody libraries, and another four from human B cells.

From the data above, it is clear that transgenic mice have played a much larger role to date than antibody libraries in sourcing successful candidates that have either reached approval stage or late stage clinical trials.  That may or may not tell the whole story, however, as target selection, financing, collaborations, and clinical expertise of the four innovative companies mentioned above, dating back to the pre-2005 timeframe also would have a huge impact on those programs that ultimately were successful and represented by these data.  I do believe, however, that the overall numbers don’t lie, and that for many targets, including soluble cytokines or other serum proteins and single pass receptors with prominent exodomains, the combination of which make up the vast majority of antibody targets, immunization of a transgenic animal should lead rapidly to high quality, high affinity antibodies.  When it comes to isolating epitopes, certain infectious disease targets, and multi-pass membrane proteins, however, often times human antibody library display approaches may have an edge to obtain the right antibody to develop.

Historically, there has been a preconception, largely supported by various data, that antibodies derived from animals or mammalian cells were generally “better behaved” than antibodies derived from human antibody libraries (Jain et al., 2017).  Many papers have been written supporting various aspects of this argument, including the case against hydrophobic patches found in library-based antibodies, the case for phage-based sequence bias, the lack of mammalian cell “editing”, the need for in vitro affinity maturation, and so forth.  Some of these arguments may apply to some library-sourced antibodies, but likely not to all of them.  Many human antibody library antibodies in fact are derived from human antibody genes using PCR-based approaches.  Depending on the maturation level of the recovered variable sequences, one would expect that many of these structures might be more “animal like”, even if they have not gone through substantial in vivo editing.  Moreover, more and more library-based approaches are using eukaryotic cells (e.g., yeast, mammalian cells) for expression and display of their antibodies, which should improve the selection for antibodies with improved expression, folding, and solubility characteristics.

There are now more than a dozen transgenic animal platforms available today, ranging from the original Medarex HuMab mouse and the Abgenix Xenomouse, to transgenic rats, rabbits, chickens, and even cows producing human antibodies, so there is no shortage of potential transgenic animal platforms from which to derive human antibodies (Strohl, 2017).  Moreover, most companies using these approaches have moved away from low yield hybridomas to high yield and throughput B cell cloning approaches, substantially increasing the ability to obtain high quality clones from animals.

Likewise, for displayed antibodies, the field has progressed significantly from phage displayed scFv or Fab human antibody libraries from CaT and Morphosys, respectively, to libraries generated and panned in yeast, mammalian cells, and most recently, in recombinant mammalian cells in which the antibodies are matured “in cell”.  Thus, the range of display options, combined with FACS sorting and analysis, next generation sequencing, and tagging technologies, have significantly increased the ability to obtain large numbers of high quality antibodies from human antibody libraries.

The critical quality attributes of a human antibody panel are: (i) the ability to bind and neutralize key “functional” epitopes; (ii) high affinity and selectivity; (iii) proper biophysical properties (e.g., “well-behaved”, soluble, not aggregation-prone, biochemical stability); (iv) excellent expression as full-length antibodies in manufacturing cell lines; and (v) lack of immunogenicity when dosed in humans.  While virtually any of the approaches discussed above can ultimately end up with excellent attributes in each category, it is likely that, for most targets, antibodies sourced from transgenic animals will be more likely to achieve all the attributes more easily and quickly than those sourced from traditional human antibody libraries.  This may evolve, however, as improved cell-based maturation and panning approaches, such the HuTARG™ technology developed by Innovative Targeting Solutions in Vancouver, which couples mammalian display with cell-based V(D)J recombination and FACS sorting, may revolutionize how fully human antibody variable sequences are sourced in the future.

References:

Strohl WR.  2017.  Chapter 5.  Human antibody discovery platforms, pp. 115-160.  Protein Therapeutics, 2 Volume Set.  T. Vaughan, J. Osbourn, B. Jallal, R. Mannhold, G. Folkers, H. Buschmann, eds.  Wiley.  ISBN: 978-3-527-34086-6.

Jain T, Sun T, Durand S, Hall A, Houston NR, Nett JH, Sharkley B, Bobrowitz B, Caffry I, et al.  2017.  Biophysical properties of the clinical-stage antibody landscape.  Proc. Nat’l. Acad. Sci. USA 114:944-949.

Happy antibody hunting…

Bill Strohl, www.bistrobiotech.com

Filed Under: Antibody discovery Tagged With: antibody therapeutics, phage display, transgenic mouse

The INNs and outs of antibody international nonproprietary names

January 4, 2016 by The Antibody Society

Recently, the World Health Organization (WHO) introduced new definitions for the assignment of antibody international nonproprietary names (INN). The modifications that already have been effectuated change the way in which therapeutic antibodies are classified as chimeric, humanized and human antibodies. Unfortunately, the new definitions have several major limitations that are unworkable – click here for Paul Carter’s summary.
The Antibody Society intends to represent the Antibody Community at large at an Open Session of the WHO in Geneva on April 12, 2016, and request urgent modifications that address the problems with the new system. To be able to influence the WHO, we need your support. You can support our effort by agreeing to the statement here and provide your name and information.

Filed Under: Ab news, Approvals

Antibodies to watch in 2016

December 31, 2015 by The Antibody Society

Seven novel antibody therapeutics (begelomab, bezlotoxumab, brodalumab, ixekizumab, obiltoxaximab, sarilumab, reslizumab) are undergoing regulatory review as of December 2015, and thus may gain their first approvals in 2016. Commercial late-stage antibody therapeutics development has exceeded expectations by increasing from 39 candidates in Phase 3 studies as of late 2014 to over 50 as of late 2015. Of these candidates, transitions to regulatory review by the end of 2016 are projected for 8 (atezolizumab, benralizumab, bimagrumab, durvalumab, inotuzumab ozogamicin, lebrikizumab, ocrelizumab, tremelimumab). Other “antibodies to watch” include 15 candidates (bavituximab, bococizumab, dupilumab, fasinumab, fulranumab, gevokizumab, guselkumab, ibalizumab, LY2951742, onartuzumab, REGN2222, roledumab, romosozumab, sirukumab, Xilonix) undergoing evaluation in Phase 3 studies that have estimated primary completion dates in 2016. As evidenced by these therapeutics, the biopharmaceutical industry has a highly active late-stage clinical pipeline that may deliver numerous new products to the global market in the near future.

Filed Under: Ab news, Approvals

2015: An extraordinary year for first marketing approvals of antibody therapeutics

December 30, 2015 by The Antibody Society

The number of novel antibody therapeutics that received a first marketing approval in 2015 exceeded expectations, with 8 (alirocumab (Praluent®), elotuzumab (Empliciti®), evolocumab (Repatha®), daratumumab (Darzalex®), dinutuximab (Unituxin®), idarucizumab (Praxbind®), mepolizumab (Nucala®), necitumumab (Portrazza)) granted their first approval as of late December. A total of 9 antibody therapeutics were granted a first US approval in 2015, including all 8 antibodies noted above as well as secukinumab (Cosentyx®), which received a first approval in Japan in 2014. In the European Union, the European Commission also granted marketing approvals to 9 antibody therapeutics in 2015, including 5 antibodies noted above ((alirocumab (Praluent®), evolocumab (Repatha®), dinutuximab (Unituxin®), idarucizumab (Praxbind®), mepolizumab (Nucala®)) and 4 products that had been previously approved in another country. A table of therapeutic monoclonal antibodies approved or in review in the European Union or the United States can be found in the Members Only section of The Antibody Society’s website.

Filed Under: Ab news, Approvals

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